IDMP - IDentification of Medicinal Products From concept ... · 31 March, 2016 Rens van den Boomen...

Confidential - Property of Navitas - 2015

IDMP - IDentification of Medicinal Products

From concept to reality

31 March, 2016

Rens

van den Boomen

Presented by

Navitasnets host live webcast events


2

Agenda

IDMP concepts and regulatory update

IDMP compliance, what does it mean?

IDMP and labelling

IDMP and Serialisation

Introducing the IDMP xNetworks working group

Next Navitas webinars & forums

Q&A


3

ISO IDMP is a global standard, with EMA and EU NCAs

as early adopters

It is an ISO Standard (163 members)

ISO member countries with a national standards body and ISO voting rights

Correspondent members (countries without a national standards body)

Subscriber members (countries with small economies)

IDMP


4

IDMP data describes what a product is, where it is

authorised, how it looks, and where its parts come from

Ingredients & Substances

Ingredients

Substances

Strengths

Medicinal Product

Name

Identification

Classification

Market Authorisations

Marketing Approvals

Legal status

Countries

Manufacturing

Organisations

Operation Types

Identification

Packaging

Container

Packed Items

Clinical Particulars

Therapeutic indication

Undesired effects

Contraindications

Pharmaceutical Particulars

Dosage form

Route of admin

Units of presentation

IDMP

243data points


5

IDMP introduces unique IDs at every stage of the supply

chain for full traceability and transparency

RMs IMs FGs

MFG Primary

Packaging

2ndary

Packaging

Distribution

NetworksHCPs &

Patients

Components

BAID_2

API

Excipient

BAID_1

PCID

PHPID

MPID

SID


6

EMA has published and extended the timeline for IDMP

implementation in alignment with their SPOR initiative

Source: Minutes of EU ISO IDMP Task Force meeting 19 February 2016 -

http://www.ema.europa.eu/docs/en_GB/document_library/Minutes/2016/03/WC500203327.pdf

http://www.ema.europa.eu/docs/en_GB/document_library/Minutes/2016/03/WC500203327.pdf


7

IDMP key regulatory messages

Timeline for P&S it. 01 has been moved forward to a later date with approx.

9 months

Publication of EU IGs moved from H2 2016 Q1/Q2 2017

Kick off P&S it. 01 moved from Q1 2017 Q1/Q2 2018

Enforcement of P&S it. 01 moved from Q2 2018 Q3/Q4 2018

Product it. 02 not mentioned in updated timeline

Number of data attributes for it. 01 slightly reduced

2016 is all about:

controlled vocabularies, operating models for CVs, unique IDs and exchange of

product information, technical specifications and finalisation of IGs

Our advice:

Disconnect yourself (slightly) from EMA timelines and associate IDMP implementation to

solving a real-time business challenge


8

Agenda



IDMP and labelling




Q&A


9

Today, wherever a product is released into the market

the approved label requires to be in complete alignment

Compliance

“Today”

=Product

Released

Approved

Label

Region/Country

MAH


10

In the future the approved IDMP data set (snapshot) for

each of those markets is to be included into this mix

Region/Country

MAH

=

Product

Released

Approved

IDMP SetApproved

Label

Compliance

“Today” “Future”

=Product

Released

Approved

Label

Region/Country

MAH


11

Today global operating company have to maintain hundreds of

labels plus deviations for every market release

X times # of registrations and packs per market


12

On top of that, with the introduction of IDMP, global operating

companies have to maintain IDMP snapshots for each market

X times # of registrations and packs per market


13

How do you ensure full control of your product releases,

labels and IDMP data sets on a global scale?

MAH

“Compliance”


14

Agenda



IDMP and labelling




Q&A


15

SmPC, PIL, PSUR, PBRER etc. are an integrated part of the IDMP

data set

This means:

1. Changes to these documents

equals a change to IDMP data sets

2. Both are version controlled and

need to remain uniquely linked

together

SmPC

PIL

PSUR /

PBRER

…

ISO 11615 sec 3.1.72:

any document issued by a Medicines Regulatory Agency in

the context of the regulatory process to grant, maintain or

update the authorization of a Medicinal Product or in the

regulatory process of the authorization and supervision of

clinical trials


16

All product information used in those documents are

detangled and part of the structured IDMP data model


17

This allows you to make IDMP an integrated part of your

change control and associated labelling processes

Submission to NCA

Submission to EMA

IDMP Process

Labelling Process

Business Processes

Data Management Processes

Exchange of Product InformationTrigger

(Change Control)

IDMP Submissions

Label submissions

Submission Processes

∆ discrepancies equal questions from regulators


18

Change Control Process

Submission processes

Label business processes

IDMP data management processes

IDMP data management will accelerate the labelling process,

allow for tighter change control and IDMP compliance reporting

Auto-Reports

SmPC

PIL

PSUR / PBRER

IDMP submission

Pre-population of Regulatory documents

Author finalising the

label for submission

Manual Authoring

System

Updated label

Trigger:

Label Change

Change

owner

,,,

Author(s)IDMP Impact Assessment

Update/build IDMP record(s)

Functional

SMEs

IDMP change

owner

Times x registrations impacted

Review/approve changes

IDMP

approver

Label / IDMP Submissions

Submission

Owner

IDMP submission

Report


19

Benefits

Improved patient safety

Reduced lead times to bring critical safety information into the market place

Acceleration of labelling process

Reduction of lead-times, handovers and forms to be used

Auto population of key regulatory documents (SmPC, PIL, PSURs, etc.)

eLabelling and E2E tracking of Risk Minimisation Measures

Standardisation of structured product information

Precursor for business analytics/big data

Part of master data initiatives and data integration

IDMP compliance

Improved brand protection


20

Agenda



IDMP and labelling




Q&A


21

The journey from a decision to change the label to release in

market is long and requires tracking and tight control

Multiple Years

Timeline 1 – Variation A / Deviation X

Timeline 2 – Variation B / Deviation Y

Timeline 3 – Variation C / Deviation Z

etc…

Supply Chain

Implementation

Health

Authority

negotiation

Preparation

and dispatch

of core

submission

pack

Confirm

need

for label

change

Translation

and local

submission

Management

& tracking

of Deviations

Artwork

preparation

Update product

info in public

domain

Safety changes

New products

Technical

changes

Non-safety /

other changes

Label in

market


22

If tracking would be done today, we need to map and link

up existing identifiers between processes and systems

SKU 1

SKU 2

Change Control

Registration Database

Artwork BOM Batch Records

CR #

MA #

Art ID 1

Art ID 2

MA Pack 1

MA Pack 2

Batch #

SKU

BOM 1

BOM 2

Batch #

QMS

RIMS

ArtworkRIMS

DMS

ERP

1..*

1..*

1..*

1..*

Pro

ced

ure

sU

niq

ue

Iden

tifi

ers

Supply Chain

Implementation

Health

Authority

negotiation

Preparation

and dispatch

of core

submission

pack

Confirm

need

for label

change

Translation

and local

submission

Management

& tracking

of Deviations

Artwork

preparation

Update product

info in public

domain

Safety changes

New products

Technical

changes

Non-safety /

other changes

Label in

market

Raise CR

Close CR


23

IDMP unique IDs

Serialisation

IDMP introduces IDs at every stage of the supply chain;

Serialisation introduces traceability in the distribution network


24

Serialisation together with IDMP enables E2E tracking of

safety measures and associated label changes

Supply Chain

Implementation

Health

Authority

negotiation

Preparation

and dispatch

of core

submission

pack

Confirm

need

for label

change

Translation

and local

submission

Management

& tracking

of Deviations

Artwork

preparation

Update product

info in public

domain

Safety changes

New products

Technical

changes

Non-safety /

other changes

Label in

market

Pro

ced

ure

s

Raise CR

IDMP (July 2016 onwards)

Serialisation* (2017 & Feb 2019)

PCID

MPID

GTIN

CR#

BAID(2)

Un

iqu

e

Iden

tifi

ers

Registration Level

Package Registration Level

Individual Pack Level

1..*

1..*

1..*

1..*

*Global Trade Identification Number

*US: Drug Supply Chain Security Act (2017)EU: Falsified medicine Act (2019)

Change Control

Close CR

SN1..*

Batch #1..*


25

Data carriers (i.e. GTIN) are an integrated part of the

IDMP data model

Packaged Item Container

Packaged Medicinal Product

Data Carrier Identifier

GTIN

PCID

Medicinal Product

MPID

1..*

1..*

0..*

11615

BatchIdentifier

BAID(2)

0..*

(Outer Package)

Split into individual components


26

IDMP compliance means being in full control of your product

information for any product released in any market

Oversight

Build, manage and maintain IDMP content

including regulatory documents

corresponding to deviating market

requirements

Proactive management of workload and QC

of IDMP records throughout the building,

submission as well as product release

phases

Transparency

Ability to track the deviations and decisions

corresponding to them

Version control and information retention

Traceability

Ability to extract/maintain tracking information

of key E2E tracking points with introduction

of IDMP unique IDs and Serialisation

=

Product

Released

Approved

IDMP SetApproved

Label

Transparency


27

Agenda



IDMP and labelling




Q&A


28

Navitas would like to facilitate a xNetworks IDMP

working group

What would you get out of it (purpose)?Topic examples could include:

Labelling & Serialisation

Regulatory documents (SmPc, PIL, PSUR, PBRER, etc.)

Pharmacovigilance (E2B_R3, commitment tracking, etc.)

Product Quality Complaints

…

Exact purpose will be established by its member during first call

Solution orientated, best practices, driving business improvements

How would we work (commitment)?Teleconference (every 1 or 2 months)

Work packages, supported by Navitas SMEs

F2F breakout sessions during forums

Interested?Please send an email to [email protected]

mailto:[email protected]


29

Agenda



IDMP and labelling




Q&A


30

Upcoming 2016 Navitasnets Spring Forum dates

Network

Spring Dates 2016Timings 09.30 – 16.30

New York London

14 June – forum

13 June - HoS21 June

16 June 23 June

15 June 22 June

15 - 16 June 24 May

14 June 25 May

Early June /

NEW! 15 June /CDS

RoundTable


31

2016/7 will see the continuation of quarterly webcasts to

hear the latest best practice

Latest Regulatory context for

IDMP

IDMP – 5 steps to success

Maturity assessment

Strategy roadmap

Program management

System implementation

IDMP deployment

Case study – tbc?

Where next

A reminder of why E2E tracking

is key

Regulatory scrutiny / E2E

model

The start and end point of

labelling

Key milestones, timelines,

interfaces

Tracking tools in action

A portfolio of tools

Success stories

Preventing pitfalls ,

Reaping benefit

Looking forward

IDMP

From concept to reality

31st March 2016

Global PV connections

Managing across borders

18th Feb 2016

Navitasnets host live webcast events

The shifting global PV context

Shifting regs, Complex landscape

Rising volumes , headcount sqeeze

Building global connections

Managing across borders –

affiliates, partners

Assessing risk and resource needs

Strategies for success

Governance in action

Success stories (case stud

examples

Preventing pitfalls , Reaping benefit

Looking forward?

E2E labelling

“Tracking tools in action”

14th April 2016


32

Agenda



IDMP and labelling




Q&A


33

Questions?


34

Thank you for listening

[email protected]

M: +44 (0) 7766 107514

USANavitas Inc.

502 Carnegie Center

Suite 100, Princeton,

NJ 08540, USA

Tel: +1 609 720 1002

EUNavitas Life Sciences Limited

Parklands Business Park,

Forest Road, Denmead

Hampshire, PO7 6XP, UK

Tel: +44 (0) 2392 268133

IndiaNavitas LLP

2nd Floor, Block – A1

Shriram “The Gateway SEZ”

No. 16, GST Road, Perungalathur

Chennai-600063, India

NJ 08540

Tel: +91 44 4590 9000

www.navitas.net

[email protected]


http://www.navitas.net/


IDMP - IDentification of Medicinal Products From concept ... · 31 March, 2016 Rens van den Boomen...

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Transcript of IDMP - IDentification of Medicinal Products From concept ... · 31 March, 2016 Rens van den Boomen...